Clinical trial · Interventional
Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Development and Feasibility of a Virtual Remote Physiological Monitoring Program of Children With Heart Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities. This creates challenges for children and families who need to travel long distances to come to appointments. Providing quality care to children with heart disease has further been challenged by the COVID-19 pandemic, with a shift towards decreased in-person contact and an increase in virtual visits, where assessment by doctors and nurses is more limited. This research study will look at how families of children with heart disease access care and how investigators can improve care with virtual technologies. This will involve testing a new home-based virtual care platform that uses Bluetooth technology to connect weight scales, oxygen measuring devices and blood pressure cuffs with a smartphone app, allowing parents to easily use these devices and send accurate data directly to the cardiology team. Investigators will obtain feedback from families, patients, and healthcare providers about how this helped or did not help them, and adjust the technology as needed to make it better.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biventricular Congestive Heart Failure | — | UNRESOLVED | — |
| Congenital Heart Disease | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Heart Failure，Congestive | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Single-ventricle | — | UNRESOLVED | — |
| Transplant; Failure, Heart | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remote physiological monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Remote physiological monitoring
- description
- Patients will be recruited from inpatient and outpatient cardiology service at the Stollery Children's Hospital will be purposively selected, with 50% of the patients living at least 100km from the Stollery into one of the following groups: Group 1: Infants \<12 months of age with single ventricle physiology or biventricular cyanotic congenital heart disease. Group 2: Patients aged 5-17 with heart failure, listed for transplant, or within 1 year of transplant.
- interventionNames
- Device: Remote physiological monitoring
Primary outcomes (1)
- measure
- Acceptability of technology
- timeFrame
- 3-weeks
- description
- We will ascertain adherence with the protocol by determining the mean number of requested assessments performed and the proportion of participants who complete \>80% of measurements. This will contribute to our understanding of the acceptability of this technology from the patient and family perspective.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of Pediatric Cardiology at the Stollery Children's Hospital in Edmonton, AB * Group 1: infants \<12 months of age with single ventricle physiology or biventricular cyanotic congenital heart disease * Group 2: patients aged 5 to 17 years with heart failure, listed for heart transplant, or within 1-year of heart transplant * English speaking * Access to internet either in the household or within the community Exclusion Criteria: * Inability to use technology due to physical or cognitive impairment in the caregiver * Non-English speaking (thus limiting communication during qualitative interviews) * No access to the internet (thus unable to transmit the device data through the app or be able to complete the qualitative interview)
References
Publications (9)
- BACKGROUNDLorch SA, Rogowski J, Profit J, Phibbs CS. Access to risk-appropriate hospital care and disparities in neonatal outcomes in racial/ethnic groups and rural-urban populations. Semin Perinatol. 2021 Jun;45(4):151409. doi: 10.1016/j.semperi.2021.151409. Epub 2021 Mar 21. PMID 33931237
- BACKGROUNDChoi SA, Lim K, Baek H, Yoo S, Cho A, Kim H, Hwang H, Kim KJ. Impact of mobile health application on data collection and self-management of epilepsy. Epilepsy Behav. 2021 Jun;119:107982. doi: 10.1016/j.yebeh.2021.107982. Epub 2021 May 1. PMID 33946011
- BACKGROUNDPadwal R, Wood PW. Digital Health Approaches for the Assessment and Optimisation of Hypertension Care Provision. Can J Cardiol. 2021 May;37(5):711-721. doi: 10.1016/j.cjca.2020.12.009. Epub 2020 Dec 17. PMID 33340672
- BACKGROUNDPadwal RS, So H, Wood PW, Mcalister FA, Siddiqui M, Norris CM, Jeerakathil T, Stone J, Valaire S, Mann B, Boulanger P, Klarenbach SW. Cost-effectiveness of home blood pressure telemonitoring and case management in the secondary prevention of cerebrovascular disease in Canada. J Clin Hypertens (Greenwich). 2019 Feb;21(2):159-168. doi: 10.1111/jch.13459. Epub 2018 Dec 20. PMID 30570200
- BACKGROUNDHehir DA, Ghanayem NS. Single-ventricle infant home monitoring programs: outcomes and impact. Curr Opin Cardiol. 2013 Mar;28(2):97-102. doi: 10.1097/HCO.0b013e32835dceaf. PMID 23337893
- BACKGROUNDSiehr SL, Norris JK, Bushnell JA, Ramamoorthy C, Reddy VM, Hanley FL, Wright GE. Home monitoring program reduces interstage mortality after the modified Norwood procedure. J Thorac Cardiovasc Surg. 2014 Feb;147(2):718-23.e1. doi: 10.1016/j.jtcvs.2013.04.006. Epub 2013 May 8. PMID 23663957
- BACKGROUNDCastellanos DA, Herrington C, Adler S, Haas K, Ram Kumar S, Kung GC. Home Monitoring Program Reduces Mortality in High-Risk Sociodemographic Single-Ventricle Patients. Pediatr Cardiol. 2016 Dec;37(8):1575-1580. doi: 10.1007/s00246-016-1472-x. Epub 2016 Aug 23.